This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Vinageras, E. N. Articles by Dávila, A. L. Search for Related Content PubMed PubMed Citation Articles by Vinageras, E. N. Articles by Dávila, A. L. Related Articles Related Editorial Social Bookmarking                            What's this?

Phase II Randomized Controlled Trial of an Epidermal Growth Factor Vaccine in Advanced Non–Small-Cell Lung Cancer

Elia Neninger Vinageras, Ana de la Torre, Marta Osorio Rodríguez, Mauricio Catalá Ferrer, Idania Bravo, Mario Mendoza del Pino, Daniel Abreu Abreu, Soraida Acosta Brooks, Rolando Rives, Concepción del Castillo Carrillo, Marta González Dueñas, Carmen Viada, Beatriz García Verdecia, Tania Crombet Ramos, Gisela González Marinello, Agustín Lage Dávila

From the Hermanos Ameijeiras Hospital; National Institute of Oncology and Radiobiology; Center for Medical and Surgical Research; National Institute of Neumology; Center of Molecular Immunology, Havana; Celestino Hernández Hospital, Villa Clara; Third Congress Hospital, Pinar del Río; Maria Curie Hospital, Camagüey, Cuba; V.I. Lenin Hospital, Holguín; and Saturnino Lora Hospital, Santiago de Cuba

Corresponding author: Elia Neninger Vinageras, MD, Hospital Hermanos Ameijeiras, San Lázaro 701, PO Box 10300, Ciudad Habana, Cuba

Purpose We show the result of a randomized phase II clinical trial with an epidermal growth factor (EGF)-based cancer vaccine in advanced non–small-cell lung cancer (NSCLC) patients, evaluating immunogenicity, safety, and effect on survival.

Patients and Methods Eighty patients with stage IIIB/IV NSCLC after finishing first-line chemotherapy were randomly assigned to receive best supportive care or EGF vaccinations.

Results Vaccination was safe. Adverse events were observed in less than 25% of cases and were grade 1 or 2 according to National Cancer Institute Common Toxicity Criteria. Good anti-EGF antibody response (GAR) was obtained in 51.3% of vaccinated patients and in none of the control group. Serum EGF concentration showed a major decrease in 64.3% of vaccinated patients. GAR patients survived significantly more than those with poor antibody response (PAR). Also, patients whose serum EGF dropped below 168 pg/mL survived significantly more than the rest. There was a trend to an increased survival for vaccinated patients compared with controls. The survival advantage for vaccinated patients compared with controls was statistically significant in the subgroup of patients with age younger than 60 years.

Conclusion Vaccination with EGF was safe and provoked an increase in anti-EGF antibody titers and a decrease in serum EGF. There was a direct correlation between antibody response and survival. There was a direct correlation between decrease in serum EGF and survival. In patients younger than 60 years, vaccination was associated with increased survival.

Terms in blue are defined in the glossary, found at the end of this article and online at www.jco.org.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

Related Editorial

• Are Vaccines Making a Comeback in Non–Small-Cell Lung Cancer?
  John J. Nemunaitis
  JCO 2008 26: 1402-1403 [Full Text]

This article has been cited by other articles:

				C. Gridelli, A. Rossi, P. Maione, M. L. Ferrara, V. Castaldo, and P. C. Sacco Vaccines for the Treatment of Non-Small Cell Lung Cancer: A Renewed Anticancer Strategy Oncologist, September 1, 2009; 14(9): 909 - 920. [Abstract] [Full Text] [PDF]

				G. K. Dy and A. A. Adjei Emerging Therapeutic Targets in Non-Small Cell Lung Cancer Proceedings of the ATS, April 15, 2009; 6(2): 218 - 223. [Abstract] [Full Text] [PDF]

				E. A. Hirschowitz and J. R. Yannelli Immunotherapy for Lung Cancer Proceedings of the ATS, April 15, 2009; 6(2): 224 - 232. [Abstract] [Full Text] [PDF]

				J. J. Nemunaitis Are Vaccines Making a Comeback in Non-Small-Cell Lung Cancer? J. Clin. Oncol., March 20, 2008; 26(9): 1402 - 1403. [Full Text] [PDF]